Audit-Trail uses electronic signatures?

COMPUTER SYSTEM VALIDATION (CSV) SCADA AND PLC's
1

Hi:

If a PLC / SCADA system uses an audit trail, and if someone changes the value of a parameter or a state of a valve, and the user enters a correct “user name” and password, this action is stored in a database, including the user name associated to the action.

The question is: when the user accepts the action typing his “user name” and password, and all this information is available in a printed report, this could be considerate like a electronic signature?

Thanks everybody in advanced!!

2

Hi,

According to the FDA: “Persons who use electronic signatures based upon use of identification codes in combination with passwords shall employ controls to ensure their security and integrity.”

In other words, a username/password identification is considered an electronic signature if it complies with certain controls. You can find details about these controls here:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1&subpartNode=21:1.0.1.1.7.3

I hope this is useful.

Best regards,

Enrique Riis

3

Thank you Enrique, yours comments and links are very helpful

Best regards

4

Very precise explanation to the query greetings !